I 

115TH CONGRESS 

2D SESSION H. R. 5997 

To amend titles XVIII and XIX of the Social Security Act to ensure prompt 

coverage of breakthrough devices under the Medicare and Medicaid programs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 5, 2018 

Ms. DELBENE (for herself, Mrs. WALORSKI, Ms. SEWELL of Alabama, Mr. 

BILIRAKIS, and Mr. CA ́RDENAS) introduced the following bill; which was 

referred to the Committee on Ways and Means, and in addition to the 

Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions 

as fall within the jurisdiction of the committee concerned 

A BILL 

To amend titles XVIII and XIX of the Social Security Act 

to ensure prompt coverage of breakthrough devices under 

the Medicare and Medicaid programs, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Ensuring Patient Ac5 cess to Critical Breakthrough Products Act of 2018’’. 


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1 SEC. 2. COVERAGE AND PAYMENT FOR BREAKTHROUGH 

2 DEVICES UNDER THE MEDICARE PROGRAM. 

3 (a) IN GENERAL.—Part E of title XVIII of the Social 

4 Security Act (42 U.S.C. 1395x et seq.) is amended by add5 ing at the end the following new section: 

6 ‘‘SEC. 1899C. COVERAGE OF BREAKTHROUGH DEVICES. 

7 ‘‘(a) BREAKTHROUGH DEVICES.— 

8 ‘‘(1) IN GENERAL.—For purposes of this sec9 tion, the term ‘breakthrough device’ means a med10 ical device that is a device (as defined in section 201 

11 of the Federal Food, Drug, and Cosmetic Act) and 

12 that is— 

13 ‘‘(A) provided with review priority by the 

14 Secretary under subsection (d)(5) of section 

15 515 of such Act; and 

16 ‘‘(B) approved or cleared pursuant to sec17 tion 510(k), 513(f), or 515 of such Act for use 

18 in treating an indication. 

19 ‘‘(2) LIMITATION ON NUMBER OF 510(k) DE20 VICES.—With respect to a 5-year period, in no case 

21 may more than five medical devices described in 

22 paragraph (1) that are classified under section 

23 510(k) of the Federal Food, Drug, and Cosmetic 

24 Act be covered and paid for under this title by rea25 son of this section during each such 5-year period. 

26 ‘‘(b) COVERAGE.— 


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1 ‘‘(1) TRANSITIONAL COVERAGE.— 

2 ‘‘(A) IN GENERAL.—During the transi3 tional coverage period (as defined in subpara4 graph (B)) a breakthrough device shall be— 

5 ‘‘(i) deemed to be reasonable and nec6 essary for purposes of section 

7 1862(a)(1)(A); 

8 ‘‘(ii) deemed to be approved for an ad9 ditional payment under section 

10 1886(d)(5)(K); 

11 ‘‘(iii) deemed to be approved for pass12 through payment under section 1833(t)(6) 

13 and section 1833(i); and 

14 ‘‘(iv) insofar as such breakthrough de15 vice may be furnished in a setting for 

16 which payment is made under an applica17 ble payment system described in subpara18 graphs (D) through (I) of subsection 

19 (c)(4), deemed eligible for an additional 

20 payment pursuant to subsection (d)(3) 

21 when furnished in a setting for which pay22 ment is made under such an applicable 

23 payment system during such transitional 

24 coverage period. 


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1 ‘‘(B) TRANSITIONAL COVERAGE PERIOD

2 DEFINED.—As used in this section, the term 

3 ‘transitional coverage period’ means, with re4 spect to a breakthrough device, the period 

5 that— 

6 ‘‘(i) begins on the date of the approval 

7 under section 515 of the Federal Food, 

8 Drug, and Cosmetic Act or of the clear9 ance under section 510(k) of such Act, as 

10 applicable, of such device by the Secretary 

11 for the indication described in subpara12 graph (A)(ii) or (B) of subsection (a)(1), 

13 respectively; and 

14 ‘‘(ii) ends on the last day of the 3- 

15 year period that begins on the date that 

16 the Secretary, pursuant to subsection 

17 (c)(2), updates the relevant applicable pay18 ment system (as defined in subsection 

19 (c)(4)) to recognize the unique temporary 

20 or permanent code or codes assigned under 

21 subsection (c)(1) to such breakthrough de22 vice, except as provided in subsections 

23 (d)(1)(B) and (d)(2)(B). 

24 ‘‘(2) PROCESS FOR REGULAR COVERAGE.—For 

25 purposes of the application of section 1862(a)(1)(A) 


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1 to a breakthrough device furnished after the transi2 tional coverage period (as defined in paragraph 

3 (1)(B)) for such device, the Secretary, acting 

4 through the Council for Technology and Innovation 

5 (established under section 1868(b)) in conjunction 

6 with the Coverage and Analysis Group of the Cen7 ters for Medicare & Medicaid Services, shall estab8 lish a process for the coverage of such breakthrough 

9 devices under this title after such period as follows: 

10 ‘‘(A) IDENTIFICATION OF ADDITIONAL EVI11 DENCE.— 

12 ‘‘(i) IN GENERAL.—With respect to a 

13 breakthrough device, not later than 1 year 

14 after the date of the approval of such de15 vice under section 515 of the Federal 

16 Food, Drug, and Cosmetic Act or of the 

17 clearance of such device under section 

18 510(k) of such Act, as applicable, the Sec19 retary shall identify whether any additional 

20 data or evidence is required with respect to 

21 any indications for such device for pur22 poses of the application of such section 

23 1862(a)(1)(A) to such device for such indi24 cations. 


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1 ‘‘(ii) NON-DUPLICATION OF DATA RE2 QUESTS.—In carrying out clause (i) with 

3 respect to a breakthrough device, the Sec4 retary shall ensure that data or evidence 

5 identified— 

6 ‘‘(I) does not duplicate data re7 quired to be collected by the Food and 

8 Drug Administration with respect to 

9 such breakthrough device; 

10 ‘‘(II) minimizes the administra11 tive burdens of data collection and re12 porting on providers of services, sup13 pliers, and manufacturers of break14 through devices; and 

15 ‘‘(III) is not otherwise unneces16 sary or redundant. 

17 ‘‘(B) PROPOSAL FOR COVERAGE AFTER

18 THE TRANSITIONAL COVERAGE PERIOD.—Not 

19 later than 2 years after the date of the approval 

20 or clearance of a breakthrough device by the 

21 Food and Drug Administration, the Secretary 

22 shall develop a proposal for coverage under this 

23 title of such breakthrough device for such indi24 cations as the Secretary determines to be ap25 propriate, based on the data and evidence colVerDate Sep 11 2014 06:06 Jun 06, 2018 Jkt 079200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5997.IH H5997

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1 lected under subparagraph (A), for such devices 

2 furnished after the transitional coverage period 

3 under paragraph (1) for such device. If the Sec4 retary does not, on a date that is before the end 

5 of such two-year period, take action to modify 

6 the indications for which coverage of a break7 through device may be provided under this title 

8 after such period, for purposes of section 

9 1862(a)(1)(A) coverage under this title of such 

10 breakthrough device shall be made for all indi11 cations for which such device is approved under 

12 section 515 of the Federal Food, Drug, and 

13 Cosmetic Act or cleared under section 510(k) of 

14 such Act. 

15 ‘‘(3) RULES OF CONSTRUCTION.—Nothing in 

16 this section shall be construed to— 

17 ‘‘(A) affect the ability of the manufacturer 

18 of a breakthrough device to seek approval for 

19 pass-through payment status under section 

20 1833(t)(6) or to seek approval for an additional 

21 payment under section 1886(d)(5)(K) insofar 

22 as such breakthrough device does not qualify 

23 for transitional coverage under paragraph (1); 

24 or 


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1 ‘‘(B) affect the application and approval 

2 process for pass-through payment status under 

3 section 1833(t)(6) or for an additional payment 

4 under section 1886(d)(5)(K) in the case of a 

5 medical device that is not approved by the Food 

6 and Drug Administration as a breakthrough de7 vice. 

8 ‘‘(c) CODING.— 

9 ‘‘(1) PROMPT ASSIGNMENT.—Not later than 

10 three months after the date of approval or clearance 

11 of a breakthrough device by the Food and Drug Ad12 ministration, subject to subparagraph (B), the Sec13 retary shall assign a unique temporary or permanent 

14 code or codes for purposes of coverage and payment 

15 for such breakthrough device under the applicable 

16 payment systems (described in paragraph (4)). 

17 ‘‘(2) UPDATES.— 

18 ‘‘(A) IPPS.—The Secretary shall provide 

19 for semiannual updates under the applicable 

20 payment system described in paragraph (4)(A) 

21 (relating to the inpatient hospital prospective 

22 payment system) to recognize the code or codes 

23 assigned under paragraph (1). 

24 ‘‘(B) OPPS.—The Secretary shall provide 

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1 ment system described in paragraph (4)(B) (re2 lating to the outpatient hospital prospective 

3 payment system) to recognize the code or codes 

4 assigned under paragraph (1). 

5 ‘‘(3) TRANSPARENCY.—The process for the as6 signment of a code or codes under this subsection 

7 shall provide for public notice and a meaningful op8 portunity for public comment from affected parties. 

9 ‘‘(4) APPLICABLE PAYMENT SYSTEMS DE10 SCRIBED.—For purposes of this subsection, the term 

11 ‘applicable payment systems’ means— 

12 ‘‘(A) with respect to inpatient hospital 

13 services, the prospective payment system for in14 patient hospital services established under sec15 tion 1886(d); 

16 ‘‘(B) with respect to outpatient hospital 

17 services, the prospective payment system for 

18 covered OPD services established under section 

19 1833(t); 

20 ‘‘(C) with respect to ambulatory surgical 

21 center services, the fee schedule for such serv22 ices established under 1833(i); 

23 ‘‘(D) with respect to physicians’ services, 

24 the physician fee schedules established under 

25 section 1848; 


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1 ‘‘(E) with respect to covered items of dura2 ble medical equipment, the applicable fee sched3 ules established under section 1834; 

4 ‘‘(F) with respect to diagnostic laboratory 

5 tests, the fee schedule established under section 

6 1834(h), the payment amounts under section 

7 1834A, and the fee schedules establish under 

8 section 1848, as the case may be; 

9 ‘‘(G) with respect to inpatient hospital 

10 services furnished by rehabilitation facilities, 

11 the prospective payment system established 

12 under section 1886(j); 

13 ‘‘(H) with respect to inpatient hospital 

14 services furnished by long-term care hospitals, 

15 the prospective payment system under section 

16 1886(m); and 

17 ‘‘(I) with respect to inpatient hospital serv18 ices furnished by psychiatric hospitals and psy19 chiatric units, the prospective payment system 

20 under section 1886(s). 

21 ‘‘(d) PAYMENT.— 

22 ‘‘(1) INPATIENT HOSPITAL PROSPECTIVE PAY23 MENT SYSTEM: DEEMED ELIGIBILITY FOR BREAK24 THROUGH PAYMENT.—The Secretary shall deem 

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1 tional payment under section 1886(d)(5)(K) for the 

2 3-year period that begins— 

3 ‘‘(A) except as provided in subparagraph 

4 (B), on the date that the Secretary, pursuant to 

5 subsection (c)(2)(A), updates the payment sys6 tem under section 1886(d) to recognize the 

7 unique temporary or permanent code or codes 

8 assigned under subsection (c)(1) to such break9 through device; or 

10 ‘‘(B) in the case of a device that has not 

11 received approval or clearance as a break12 through device by the Food and Drug Adminis13 tration before such payment system is updated 

14 under subsection (c)(2)(A) to recognize the 

15 unique temporary or permanent code or codes 

16 assigned under subsection (c)(1) to such device, 

17 on the date of such approval or clearance. 

18 Nothing in this paragraph shall be construed to af19 fect the authority of the Secretary to use claims 

20 data to establish new diagnosis or procedure codes 

21 for breakthrough devices or to identify appropriate 

22 diagnosis-related groups for the assignment of 

23 breakthrough devices under annual rulemaking to 

24 carry out section 1886(d)(5)(K). 


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1 ‘‘(2) OUTPATIENT PROSPECTIVE PAYMENT SYS2 TEM: DEEMED ELIGIBILITY FOR PASS-THROUGH

3 PAYMENT.—The Secretary shall deem each break4 through device as approved for pass-through pay5 ment under section 1833(t)(6) (including for pur6 poses of section 1833(i)(2)(D)) during the 3-year pe7 riod that begins— 

8 ‘‘(A) except as provided in subparagraph 

9 (B), on the date that the Secretary, pursuant to 

10 subsection (c)(2)(B), updates the payment sys11 tem under section 1833(t) to recognize the 

12 unique temporary or permanent code or codes 

13 assigned under subsection (c)(1) to such break14 through device; or 

15 ‘‘(B) in the case of a device that has not 

16 received approval or clearance as a break17 through device by the Food and Drug Adminis18 tration before such payment system is updated 

19 under subsection (c)(2)(B) to recognize the 

20 unique temporary or permanent code or codes 

21 assigned under subsection (c)(1) to such device, 

22 on the date of such approval or clearance. 

23 Nothing in this paragraph shall be construed to af24 fect the authority of the Secretary to use claims 

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1 tion groups for breakthrough devices or to revise 

2 such groups to take into account breakthrough de3 vices under annual rulemaking to carry out section 

4 1833(t). 

5 ‘‘(3) OTHER PAYMENT SYSTEMS.— 

6 ‘‘(A) IN GENERAL.—In the case of break7 through device that is furnished and for which 

8 payment may be made under the payment sys9 tem established under section 1819(a), 1834, 

10 1834A, 1848, 1886(j), 1886(m), 1886(s), or 

11 1895 or any other relevant provision of this 

12 title (other than sections 1833(i), 1833(t), and 

13 1886(d)), the Secretary shall provide for an ad14 ditional payment for such breakthrough device 

15 under such payment system in an amount equal 

16 to 80 percent of the costs of such breakthrough 

17 device. 

18 ‘‘(B) RULE OF CONSTRUCTION.—Nothing 

19 in this paragraph shall be construed to affect 

20 the authority of the Secretary to use claims 

21 data to establish new or modify existing ambu22 latory payment classification groups, diagnosis23 related groups, level II HCPCS codes or such 

24 other groups or codes as the Secretary may es25 tablish under the annual rulemaking authority 


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1 under the provisions referred to in subpara2 graph (A). 

3 ‘‘(4) PAYMENT FOR BREAKTHROUGH DEVICES

4 AFTER THE TRANSITIONAL COVERAGE PERIOD.— 

5 Payment for a breakthrough device that is furnished 

6 after the conclusion of the transitional coverage pe7 riod under subsection (b)(1) for such device shall be 

8 made pursuant to the applicable payment system in9 volved, taking into account the additional evidence 

10 and data collected under subsection (b)(2). 

11 ‘‘(e) TREATMENT OF BREAKTHROUGH DEVICES

12 UNDER ALTERNATIVE PAYMENT MODELS.— 

13 ‘‘(1) ALTERNATIVE PAYMENT MODEL DE14 FINED.—In this subsection, the term ‘alternative 

15 payment model’ means, with respect to items and 

16 services for which payment is made under the appli17 cable payment systems under this title, payment ini18 tiatives designed to improve the quality, efficiency, 

19 and overall value of health care furnished to individ20 uals entitled to benefits under part A or enrolled 

21 under part B through financial incentives to pro22 viders of services and suppliers for meeting or ex23 ceeding certain quality or performance measures or 

24 through financial penalties on providers that fail to 


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1 achieve specified goals or cost savings, or both. Such 

2 term includes— 

3 ‘‘(A) the Medicare shared savings program 

4 under established section 1899; 

5 ‘‘(B) shared savings programs tested by 

6 the Center for Medicare and Medicaid Innova7 tion under section 1115A; 

8 ‘‘(C) the National Pilot Program on Pay9 ment Bundling under section 1866D; 

10 ‘‘(D) bundled payment programs tested by 

11 the Center for Medicare and Medicaid Innova12 tion under section 1115A; and 

13 ‘‘(E) any other similar program conducted 

14 under this title or under applicable authorities 

15 under title XI. 

16 ‘‘(2) EXCLUSION OF ADDITIONAL COSTS OF

17 BREAKTHROUGH DEVICES.—Insofar as the amount 

18 of payment for a breakthrough device exceeds the 

19 amount of payment that the item or service would 

20 otherwise receive under an alternative payment 

21 model for which shared savings or shared losses are 

22 calculated, the Secretary shall exclude from the cal23 culation of such shared savings or losses under such 

24 program for such period the amount by which the 

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1 ceeds the payment amount for such other item or 

2 service that would have been made but for the use 

3 of the breakthrough device. 

4 ‘‘(3) ADJUSTMENT TO QUALITY PROCESS MEAS5 URES FOR BREAKTHROUGH DEVICES.— 

6 ‘‘(A) IN GENERAL.—In the case that the 

7 furnishing by a provider of services or supplier 

8 participating in an alternative payment model 

9 of a breakthrough device to an individual enti10 tled to benefits under part A or enrolled under 

11 part B and participating in such program would 

12 result in such provider or supplier, with respect 

13 to the condition and episode of care for which 

14 such device is furnished, receiving a poor or 

15 failing score for a quality measure under such 

16 program that measures whether such provider 

17 or supplier gave the treatment known to give 

18 the best results for most patients with a par19 ticular condition (commonly known as a ‘clinical 

20 process of care’ measure), the Secretary shall 

21 exclude such quality measure from any deter22 mination of whether such provider or supplier 

23 met applicable quality performance thresholds 

24 under such program with respect to such condi25 tion and episode of care of such individual. 


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1 ‘‘(B) INAPPLICABILITY TO CLINICAL OUT2 COMES MEASURES.—Nothing in subparagraph 

3 (A) may be construed to allow for the exclusion, 

4 with respect to a breakthrough device furnished 

5 to an individual by a provider or supplier under 

6 an alternative payment model, of any quality 

7 measure designed to reflect the results of care 

8 furnished to such individual by such provider or 

9 supplier (commonly known as a ‘clinical out10 come’ measure) from a determination described 

11 in such subparagraph.’’. 

12 (b) STUDY ON LIMIT OF 510(k) BREAKTHROUGH

13 DEVICES.— 

14 (1) STUDY.—The Secretary of Health and 

15 Human Services shall conduct a study on the effect 

16 of the limit (under section 1899C(a)(2) of the Social 

17 Security Act, as added by subsection (a)) on the 

18 number of devices cleared under section 510(k) of 

19 the Federal Food, Drug, and Cosmetic Act (21 

20 U.S.C. 360(k)) that are breakthrough devices for 

21 purposes of such section 1899C. 

22 (2) MATTERS EXAMINED.—In conducting the 

23 study described in paragraph (1), the Secretary 

24 shall— 


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1 (A) determine the number of medical de2 vices cleared under such section 510(k) during 

3 the 5-year period beginning on the date of the 

4 enactment of this Act; 

5 (B) determine the number of such devices 

6 that were not breakthrough devices for pur7 poses of such section 1899C by reason of the 

8 limitation under subsection (a)(2) of such sec9 tion; and 

10 (C) examine the impact of such limitation 

11 on access to such devices for individuals entitled 

12 to benefits under part A or enrolled in part B 

13 of title XVIII of the Social Security Act (42 

14 U.S.C. 1395 et seq.). 

15 (3) REPORT.—Not later than 6 years after the 

16 date of the enactment of this Act, the Secretary 

17 shall submit to Congress a report on the study con18 ducted under this subsection and shall include such 

19 recommendations for legislative or administrative 

20 changes as the Secretary determines to be appro21 priate. 

22 (c) MODIFICATIONS TO THE COUNCIL FOR TECH23 NOLOGY AND INNOVATION.— 

24 (1) EXPANSION OF DUTIES.—Paragraph (3) of 

25 section 1868(b) of the Social Security Act (42 


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1 U.S.C. 1395ee(b)) is amended by adding at the end 

2 the following: ‘‘The Council shall also coordinate ac3 tivities of the Secretary for the implementation of 

4 section 1899C (relating to breakthrough devices), es5 pecially with respect to timely coverage, coding, evi6 dence-gathering, and payment for such devices.’’. 

7 (2) REORGANIZATION WITHIN THE CMMI.— 

8 Such section is further amended— 

9 (A) in paragraph (1), by striking ‘‘within 

10 the Centers’’ and all that follows through the 

11 end and inserting ‘‘within the Center for Medi12 care and Medicaid Innovation established under 

13 section 1115A (in this subsection referred to as 

14 ‘CMMI’).’’; and 

15 (B) in paragraph (4), by striking ‘‘the Ad16 ministrator of CMS’’ and inserting ‘‘the Direc17 tor of the CMMI’’. 

18 (d) IMPROVEMENTS TO NTAP PAYMENT ADJUST19 MENT UNDER THE INPATIENT PROSPECTIVE PAYMENT

20 SYSTEM.— 

21 (1) PAYMENT FOR COSTS OF NEW TECH22 NOLOGIES.—With respect to hospital discharges for 

23 which payment is made under section 1886(d) of the 

24 Social Security Act (42 U.S.C. 1395ww(d)) occur25 ring on or after October 1, 2016, in calculating the 


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1 amount of the additional payment for a new medical 

2 service or technology under paragraph (5)(K) of 

3 such section with respect to such a discharge, the 

4 Secretary of Health and Human Services shall apply 

5 section 412.88 of title 42, Code of Federal Regula6 tions, as if the reference to ‘‘50 percent’’ each place 

7 it appears in such section were a reference to ‘‘80 

8 percent’’. 

9 (2) CLARIFICATION REGARDING PAYMENTS FOR

10 NEW TECHNOLOGIES.— 

11 (A) IPPS NEW TECHNOLOGY PAYMENT.— 

12 Section 1886(d)(5)(K) of the Social Security 

13 Act (42 U.S.C. 1395ww(d)(5)(K)) is amended 

14 by adding at the end the following new clause: 

15 ‘‘(x) During the period with respect to 

16 which a new medical service or technology 

17 is eligible for an additional payment under 

18 this subsection by reason of this subpara19 graph, any local coverage determination 

20 (as defined in section 1869(f)(2)(B)) that 

21 would affect the coverage of, or the addi22 tional payment under this subsection for, 

23 such new medical service or technology 

24 shall have no force or effect in law or regu25 lation.’’. 


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1 (B) CONFORMING AMENDMENT FOR OPPS

2 PASS-THROUGH PAYMENT.—Section 1833(t)(6) 

3 of the Social Security Act (42 U.S.C. 

4 1395l(t)(6)) is amended by adding at the end 

5 the following new subparagraph: 

6 ‘‘(G) PROHIBITION ON USE OF LOCAL COV7 ERAGE DETERMINATIONS TO AFFECT COV8 ERAGE OF AND PAYMENT FOR PASS-THROUGH

9 DEVICES.—During the period with respect to 

10 which a drug, biological, or medical device is eli11 gible for an additional payment under this 

12 paragraph, any local coverage determination (as 

13 defined in section 1869(f)(2)(B)) that would af14 fect the coverage of, or the additional payment 

15 under this paragraph for, such drug, biological, 

16 or medical device shall have no force or effect 

17 in law or regulation.’’. 

18 (C) EFFECTIVE DATE.—This paragraph, 

19 and the amendments made by this paragraph, 

20 shall apply with respect to items and services 

21 furnished on or after the date of the enactment 

22 of this Act, including any such item or service 

23 that is eligible on such date for an additional 

24 payment under section 1833(t)(6) of the Social 

25 Security Act (42 U.S.C. 1395l(t)(6)) or under 


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1 section 1886(d) of such Act (42 U.S.C. 

2 1395ww(d)) by reason of paragraph (5)(K) of 

3 such section, or that would have been so eligible 

4 on such date but for a local coverage deter5 mination that limits or denies coverage of and 

6 such additional payment for the item or service. 

7 (3) REVISION TO THE COST THRESHOLD.— 

8 (A) IN GENERAL.—Section 

9 1886(d)(5)(K)(ii)(I) of the Social Security Act 

10 (42 U.S.C. 1395ww(d)(5)(K)(ii)(I)) is amended 

11 by striking ‘‘75 percent’’ each place it appears 

12 and inserting ‘‘50 percent’’. 

13 (B) EFFECTIVE DATE.—The amendment 

14 made by subparagraph (A) shall take effect on 

15 the date of the enactment of this Act. 

16 (4) USE OF BEST AVAILABLE COST DATA FOR

17 MS–DRG CLASSIFICATION.— 

18 (A) IN GENERAL.—Section 1886(d)(5)(K) 

19 of the Social Security Act (42 U.S.C. 

20 1395ww(d)(5)(K)), as amended by paragraph 

21 (2)(A), is further amended by adding at the end 

22 the following new clause: 

23 ‘‘(xi) In carrying out the requirement 

24 under clause (ii)(IV) for classification of a 

25 new medical service or technology to a new 


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1 or existing diagnosis-related group after 

2 the close of the period under clause (ii)(II), 

3 the Secretary shall use the most recently 

4 available data and information on the costs 

5 of such service or technology in making 

6 such a classification for the service or tech7 nology, including data and information 

8 from surveys of providers of services and 

9 suppliers conducted by the Secretary, pri10 vate payers, health plans, physician spe11 cialty societies, or manufacturers as well as 

12 commercial price data and data from man13 ufacturer invoices.’’. 

14 (B) EFFECTIVE DATE.—The amendment 

15 made by subparagraph (A) shall take effect on 

16 the date of the enactment of this Act. 

17 (5) CRITERIA APPLIED IN MAKING SUBSTAN18 TIAL IMPROVEMENT DETERMINATIONS.— 

19 (A) IN GENERAL.—Section 1886(d)(5)(K) 

20 of the Social Security Act (42 U.S.C. 

21 1395ww(d)(5)(K)), as amended by paragraphs 

22 (2)(A) and (4)(A), is further amended by add23 ing at the end the following new clause: 

24 ‘‘(xii)(I) In making a determination 

25 under this subparagraph whether a new 


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1 medical service or technology represents an 

2 advance in medical technology that sub3 stantially improves the diagnosis or treat4 ment of Medicare beneficiaries relative to a 

5 medical service or technology that was pre6 viously available, the Secretary shall also 

7 consider whether such new medical service 

8 or technology meets one or more of the fol9 lowing criteria: 

10 ‘‘(aa) The use of the new medical 

11 service or technology can result in a 

12 reduction of the length of a hospital 

13 stay. 

14 ‘‘(bb) The use of the new medical 

15 service or technology can improve pa16 tient quality of life. 

17 ‘‘(cc) The use of the new medical 

18 service or technology can create long19 term clinical efficiencies in treatment. 

20 ‘‘(dd) The use of the new medical 

21 service or technology can address pa22 tient-centered objectives (as defined 

23 by the Secretary). 

24 ‘‘(ee) The use of the new medical 

25 service or technology decreases the 


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1 number of hospitalizations or physi2 cian visits. 

3 ‘‘(ff) The use of the new medical 

4 service or technology reduces recovery 

5 time compared to the technologies 

6 previously used. 

7 ‘‘(gg) The use of the new medical 

8 service or technology reduces device9 related complications. 

10 ‘‘(hh) The use of the new medical 

11 service or technology can result in de12 creased rate of subsequent diagnostic 

13 or therapeutic interventions (such as 

14 due to the reduced rate of recurrence 

15 of the disease process). 

16 ‘‘(ii) The use of the new medical 

17 service or technology can result in 

18 more rapid beneficial resolution of the 

19 disease process treatment. 

20 ‘‘(jj) The use of the new medical 

21 service or technology can result in de22 creased pain, bleeding, or other quan23 tifiable symptom. 

24 ‘‘(kk) The use of the new medical 

25 service or technology can meet such 


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1 other criteria as the Secretary may 

2 specify. 

3 ‘‘(II) In considering whether a new 

4 medical service or technology potentially 

5 meets the criteria under subclause (I), the 

6 Secretary shall consider the following 

7 forms of evidence: 

8 ‘‘(aa) Evidence described in well9 documented case histories, including 

10 registry data. 

11 ‘‘(bb) Studies published in peer12 reviewed journals. 

13 ‘‘(cc) Data collected in countries 

14 other than the United States so long 

15 as such data otherwise meet the cri16 teria specified in this clause.’’. 

17 (B) EFFECTIVE DATE.—The amendment 

18 made by subparagraph (A) shall take effect on 

19 the date of the enactment of this Act. 

20 (6) REVISION TO THE NEWNESS CRITERION.— 

21 (A) IN GENERAL.—Section 

22 1886(d)(5)(K)(vi) of the Social Security Act 

23 (42 U.S.C. 1395ww(d)(5)(K)(vi)) is amended— 

24 (i) by inserting ‘‘(I)’’ after ‘‘(vi)’’; and 


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1 (ii) by adding at the end the following 

2 new subclauses: 

3 ‘‘(II) Under the criteria estab4 lished under this clause with respect 

5 to the determination of whether a 

6 medical service or technology is con7 sidered new for purposes of this sub8 paragraph and subparagraph (L), the 

9 Secretary shall include devices that in10 volve a significant technological 

11 change that do not raise different 

12 questions of safety and effectiveness 

13 (in a comparison to the predicate de14 vice) and result in enhanced clinical 

15 advantages or reduced cost, even 

16 though they use the same or similar 

17 mechanism of action or are assigned 

18 to the same diagnosis-related group. 

19 ‘‘(III) Under the criteria estab20 lished under this clause with respect 

21 to the determination of whether a 

22 medical service or technology is con23 sidered new for purposes of this sub24 paragraph and subparagraph (L), the 

25 Secretary shall not disqualify a new 


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1 medical service or technology as not 

2 meeting the newness criterion solely 

3 on the basis of a finding of a de mini4 mis number of claims for such med5 ical service or technology in Medicare 

6 claims data. For purposes of this sub7 clause, the term ‘de minimis’ means, 

8 with respect to claims, an amount 

9 that is fewer than 50.’’. 

10 (B) EFFECTIVE DATE.—The amendment 

11 made by subparagraph (A) shall take effect on 

12 the date of the enactment of this Act. 

13 (7) REVISION TO THE COMMENCEMENT OF THE

14 PERIOD FOR COLLECTION OF COST DATA FOR NEW

15 TECHNOLOGIES.— 

16 (A) IN GENERAL.—Section 

17 1886(d)(5)(K)(ii)(II) of the Social Security Act 

18 (42 U.S.C. 1395ww(d)(5)(K)(ii)(II)) is amend19 ed by inserting ‘‘the later of the date that is the 

20 date of the clearance or approval by the Com21 missioner of Food and Drugs of the service or 

22 technology or’’ after ‘‘beginning on’’. 

23 (B) EFFECTIVE DATE.—The amendment 

24 made by subparagraph (A) shall take effect on 

25 the date of the enactment of this Act, and shall 


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1 apply with respect to hospital discharges for in2 patient hospital services for which payment is 

3 made under section 1886(d) of the Social Secu4 rity Act (42 U.S.C. 1395ww) occurring on or 

5 after October 1, 2016. 

6 (8) PERMITTING APPEALS OF NTAP DETER7 MINATIONS.— 

8 (A) IN GENERAL.—Section 1886(d)(5)(K) 

9 of the Social Security Act (42 U.S.C. 

10 1395ww(d)(5)(K)), as amended by paragraphs 

11 (2)(A), (4)(A), and (5)(A), is further amended 

12 by adding at the end the following new clause: 

13 ‘‘(xiii)(I) An individual or entity that 

14 submits an application for additional pay15 ment under this subparagraph for a new 

16 technology shall be entitled to administra17 tive review of an adverse determination by 

18 the Secretary with respect to such applica19 tion. 

20 ‘‘(II) The Secretary shall establish a 

21 process for administrative review for pur22 poses of subclause (I). Under such process, 

23 administrative review shall be conducted by 

24 an official of the Department of Health 

25 and Human Services (other than an offiVerDate Sep 11 2014 06:06 Jun 06, 2018 Jkt 079200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6201 E:\BILLS\H5997.IH H5997

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1 cial of the Centers for Medicare & Med2 icaid Services). Under such process, the 

3 Department official involved shall complete 

4 administrative review within 90 days of re5 ceipt of a request for such review. 

6 ‘‘(III) In the case of an application 

7 for additional payment under this subpara8 graph for a new technology that is ap9 proved under administrative review, the 

10 Secretary shall provide for such additional 

11 payment for such new technology during 

12 the period that— 

13 ‘‘(aa) begins on the date that is 

14 the first day of the first calendar 

15 quarter that begins after the date of 

16 the completion of such administrative 

17 review; and 

18 ‘‘(bb) ends on the date that is 

19 not less than 2 years and not more 

20 than 3 years after the date referred to 

21 in item (aa).’’. 

22 (B) CONFORMING AMENDMENT.—Section 

23 1886(d)(7)(B) of such Act (42 U.S.C. 

24 1395ww(d)(7)(B)) is amended by inserting ‘‘but 

25 not including a denial by the Secretary of an 


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1 application for additional payment under para2 graph (5)(K) with respect to a discharge occur3 ring on or after the date of the date of the en4 actment of the Ensuring Patient Access to Crit5 ical Breakthrough Products Act of 2018’’ after 

6 ‘‘paragraph (4)(D)’’. 

7 (C) EFFECTIVE DATE.—The amendments 

8 made by this paragraph shall take effect on the 

9 date of the enactment of this Act, and shall 

10 apply with respect to hospital discharges for in11 patient hospital services for which payment is 

12 made under section 1886(d) of the Social Secu13 rity Act (42 U.S.C. 1395ww) occurring on or 

14 after October 1, 2016. 

15 (e) CONFORMING AMENDMENTS.— 

16 (1) INPATIENT PROSPECTIVE PAYMENT SYS17 TEM.—Section 1886(d)(5)(K)(i) of the Social Secu18 rity Act (42 U.S.C. 1395ww(d)(5)(K)(i)) is amended 

19 by adding at the end the following new sentence: 

20 ‘‘Effective for discharges occurring on or after Octo21 ber 1, 2016, in the case of a new medical service or 

22 technology that is a breakthrough device (as defined 

23 in section 1899C(a)) payment for such breakthrough 

24 device shall be made for the 3-year period applicable 


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1 to such breakthrough device under section 

2 1899C(d)(1).’’. 

3 (2) OUTPATIENT PROSPECTIVE PAYMENT SYS4 TEM.—Section 1833(t)(6)(C) of such Act (42 U.S.C. 

5 1395l(t)(6)(C)) is amended by adding at the end the 

6 following new clause: 

7 ‘‘(iii) SPECIAL RULE FOR BREAK8 THROUGH DEVICES.—Notwithstanding 

9 clause (i) or (ii), or any other provision of 

10 this paragraph to the contrary, in the case 

11 of a breakthrough device (as defined in 

12 section 1899C(a)) that is furnished on or 

13 after January 1, 2019, payment under this 

14 paragraph for such breakthrough device 

15 shall be made for the 3-year period appli16 cable to such breakthrough device under 

17 section 1899C(d)(2). The provisions of this 

18 clause shall also apply for purposes of 

19 transitional pass-through payment under 

20 section 1833(i)(2)(D).’’. 

21 (f) EFFECTIVE DATE.—This section and the amend22 ments made by this section shall take effect on the date 

23 of the enactment of this Act and, unless otherwise speci24 fied in this section (or in an amendment made by this sec25 tion), shall apply to breakthrough devices (as defined in 


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1 section 1899C(a), as added by subsection (a)) approved 

2 on or after January 1, 2019. 

Æ 


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